MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES INZII RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CD001
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: ni event description: product: cd001 (10mm specimen bag catcher) lot: 1560079 expiration date: 6/10/2028 date reported to me: 10/1/2025 date of this report: 10/2/2025 doctor: [name] patient id: (b)(6).Delay in surgery: yes; approximately 2 minutes patient injury? no reported by: [name], cst in surgery product location: i currently have used/defective product in my dur area in spd per [name], ¿surgeon deployed the endocatch bag and silver metal pieces of device deployed; however, the bag portion was not attached and therefore did not open¿ result: room opened another unit and proceeded successfully.Additional information provided by [name] on 03oct2025 via email: the product is available for return.The patient wasn¿t injured.Additional information provided by [name] on 08oct2025 via email: yes, the bag completely fell off the metal supports.Yes, the tips exposed inside the patient.The bag fell off immediately upon full deployment.The actuator was pushed forward, retracted and then full deployed just when deployed - when deployed the metal pieces deployed, but the bag stayed folded up.Additional information provided by [name] on 09oct2025 via email: event date was 10/1/25.Intervention: room opened another unit and proceeded successfully.Patient status: the patient wasn¿t injured.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the specimen bag falling off the metal supports.Based on the condition of the returned unit and the description of the event, it is likely that the actuator was retracted prior to full actuation, which resulted in the specimen bag falling off upon full deployment.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: ni event description: product: cd001 (10mm specimen bag catcher) lot: 1560079, expiration date: 6/10/2028, date reported to me: (b)(6) 2025, date of this report: (b)(6) 2025, doctor: [name], patient id: (b)(6), delay in surgery: yes; approximately 2 minutes, patient injury? no, reported by: [name], cst in surgery, product location: i currently have used/defective product in my dur area in spd.Per [name], ¿surgeon deployed the endocatch bag and silver metal pieces of device deployed; however, the bag portion was not attached and therefore did not open¿ result: room opened another unit and proceeded successfully.Additional information provided by [name] on 03oct2025 via email: the product is available for return.The patient wasn¿t injured.Additional information provided by [name] on 08oct2025 via email: yes, the bag completely fell off the metal supports.Yes, the tips exposed inside the patient.The bag fell off immediately upon full deployment.The actuator was pushed forward, retracted and then full deployed just when deployed - when deployed the metal pieces deployed, but the bag stayed folded up.Additional information provided by [name] on 09oct2025 via email: event date was 10/1/25.Intervention: room opened another unit and proceeded successfully patient status: no patient injury indicated.

• Brand Name: INZII RETRIEVAL SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 23442405
• Report Number: 2027111-2025-00841
• Device Sequence Number: 8626104
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K060051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CD001
• Device Catalogue Number: 10084401
• Device Lot Number: 1560079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown